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Intellia Therapeutics, Inc. (NTLA)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 collaboration revenue was $9.11M and net loss per share was $(1.34); revenue declined year over year (Q3’23: $11.99M) but improved sequentially (Q2’24: $6.96M), while EPS improved sequentially vs Q2’24 $(1.52) .
  • Cash, cash equivalents and marketable securities were $944.7M at September 30, 2024; management reiterated funding runway into late 2026 .
  • Execution catalysts: HAELO Phase 3 for NTLA‑2002 initiated with active screening; FDA cleared IND for MAGNITUDE‑2 Phase 3 in ATTRv‑PN; MAGNITUDE Phase 3 (ATTR‑CM) enrollment tracking ahead, now at 60+ sites and >20 countries .
  • New clinical data updates flagged: AHA late‑breaking oral for NTLA‑2001 Phase 1 (ATTR‑CM) on Nov 16 (biomarkers and functional capacity); NTLA‑2002 Phase 2 detailed results published in NEJM and presented at ACAAI with majority attack‑free at 50 mg dose .

What Went Well and What Went Wrong

What Went Well

  • Rapid Phase 3 execution: HAELO (NTLA‑2002) initiated with 2:1 randomization and crossover design; enrollment expected to proceed rapidly based on strong patient/investigator enthusiasm .
  • Regulatory de‑risking: FDA cleared IND for MAGNITUDE‑2 (ATTRv‑PN) enabling a small placebo‑controlled ex‑U.S. Phase 3 trial; study designed with mNIS+7 at 18 months and serum TTR at day 29 .
  • Efficacy signals: NTLA‑2002 Phase 2 showed 77–81% mean attack rate reduction and 8/11 patients in 50 mg arm attack‑free through latest follow‑up; kallikrein reduction 86% at 50 mg; safety profile favorable .
    • Quote (CEO): “A one‑time treatment of NTLA‑2002 has the potential to be a functional cure” .

What Went Wrong

  • Top‑line financial pressure: Collaboration revenue declined YoY ($9.11M vs $11.99M) and net loss widened YoY ($135.7M vs $122.2M) driven by higher R&D to advance lead programs; revenue softness tied to AvenCell collaboration reduction .
  • Expense growth: R&D expenses increased to $123.4M from $113.7M YoY; G&A ticked up to $30.5M (vs $29.4M) with higher stock‑based comp .
  • Fair value mark‑to‑market headwind: Q3 reflected $(3.06)M change in fair value of investments (other income line), partly offsetting interest income .

Financial Results

Year-over-Year and Sequential Comparison

MetricQ3 2023Q1 2024Q2 2024Q3 2024
Collaboration Revenue ($USD Millions)$11.992 $28.935 $6.957 $9.111
Net Loss ($USD Millions)$(122.224) $(107.436) $(146.975) $(135.712)
Net Loss per Share (Basic & Diluted, $)$(1.38) $(1.12) $(1.52) $(1.34)
Total Operating Expenses ($USD Millions)$143.099 $142.938 $146.000 $153.881
R&D Expense ($USD Millions)$113.696 $111.847 $114.207 $123.380
G&A Expense ($USD Millions)$29.403 $31.091 $31.793 $30.501

Cash and Balance Sheet

MetricQ1 2024Q2 2024Q3 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$953.384 $939.873 $944.681
Total Assets ($USD Millions)$1,259.589 $1,191.536 $1,173.351
Total Liabilities ($USD Millions)$223.452 $220.474 $210.736
Stockholders’ Equity ($USD Millions)$1,036.137 $971.062 $962.615

Segment Breakdown

SegmentQ3 2024 Revenue ($USD Millions)
Collaboration Revenue (only reported)$9.111

KPIs (Program Execution)

KPIQ1 2024Q2 2024Q3 2024
MAGNITUDE (ATTR‑CM) sites active~1/3 U.S planned; 30+ patients dosed; 40+ in screening (design update) >35 sites, cleared in 12+ countries >60 sites, clearance in >20 countries; enrollment ahead of projections
HAELO (NTLA‑2002) Phase 3 statusPlanned 2H’24 start Phase 3 on track 2H’24; 50 mg dose selected Initiated; active screening; 2:1 randomization; crossover at 28 weeks
MAGNITUDE‑2 (ATTRv‑PN) Phase 3 statusFDA aligned on design; ex‑U.S., ~50 pts Plan to initiate by year‑end FDA IND cleared; initiation by year‑end; mNIS+7 primary at 18 months
NTLA‑3001 (AATD) first‑in‑humanPlan to dose in 2024 MHRA authorization; expect dosing 2H’24 On track to dose first patient by year‑end

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti‑yearFund operations into late 2026 Fund operations into late 2026 Maintained
NTLA‑2002 HAELO Phase 32H 2024Initiate in 2H 2024 Initiated; active screening Achieved
NTLA‑2001 MAGNITUDE‑2 (ATTRv‑PN)By year‑end 2024Initiate by year‑end IND cleared; initiate by year‑end De‑risked/maintained
NTLA‑3001 (AATD) first patient2H 2024Dose first patient in 2H 2024 On track to dose first patient by year‑end Reaffirmed (narrowed timing)
MAGNITUDE (ATTR‑CM) paceOngoingEnrollment tracking ahead of projections Enrollment tracking ahead; >60 sites, >20 countries Maintained/accelerated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2024)Previous Mentions (Q2 2024)Current Period (Q3 2024)Trend
HAE “functional cure” profile (NTLA‑2002)Phase 1: 95% attack rate reduction; long‑term attack‑free patients; BLA target 2026 Phase 2 topline met all endpoints; 50 mg selected; global Phase 3 on track Phase 2 detailed: 77–81% reduction; 8/11 attack‑free at 50 mg; strong patient enthusiasm Strengthening
ATTR‑CM (NTLA‑2001) positioning vs silencers/stabilizersBest‑in‑class deep TTR reductions; rapid Phase 3 start Redosing data; ~100+ sites envisioned; 35+ active; 12+ countries; adaptive design >60 sites; >20 countries; late‑breaking AHA data (biomarkers/6MWT) Accelerating
Regulatory de‑risking: ATTRv‑PNFDA aligned on ex‑U.S. placebo‑controlled design (~50 pts) Plan to initiate by year‑end FDA IND cleared; metrics mNIS+7 at 18 months; serum TTR day 29 De‑risked
AATD (NTLA‑3001) gene insertionPlan to dose 2024 MHRA authorization; 2H 2024 dosing planned On track to dose first patient by year‑end; platform expansion described Nearing clinical
Platform expansion & redosingN/AFirst clinical redosing with CRISPR (additive PD) Expanding to bone marrow, brain, muscle, lung, eye programs Broader scope
Capital allocation/runwayRunway late 2026 Runway late 2026 Runway late 2026 confirmed; cash burn ~$100M/quarter as planning baseline Maintained

Management Commentary

  • CEO framing: “We are on track to initiate our third Phase 3 study in the weeks ahead… ushering in a new era of medicine” .
  • CMO on PN trial design: “All the other drugs have been approved with placebo‑controlled study… silencers are not available in the country where the studies are being conducted” .
  • CFO on runway: “We exited the third quarter with about $945 million in cash… a conservative plan… gets us well into fourth quarter of 2026” .
  • CMO on HAE read‑through: 80% of 50 mg patients in Phase I/II appear functionally cured (attack‑free without further therapy) .

Q&A Highlights

  • Enrollment cadence: MAGNITUDE (ATTR‑CM) enrollment ahead of projections; investigators cite enthusiasm about deep, consistent TTR reduction and safety, supporting faster recruitment .
  • HAELO design: 2:1 randomization improves patient appeal; crossover option at week 28 enhances participation; Phase 3 primary endpoint weeks 5–28 to reflect steady‑state kallikrein reduction .
  • PN trial scope: Ex‑U.S. placebo‑controlled with small N; regulators aligned; no silencers permitted in study countries; mNIS+7 at 18 months .
  • AATD program: 3001 targets normal AAT levels via gene insertion; initial site set beyond New Zealand; possibility of 2025 data; albumin promoter expected to normalize AAT protein levels without major safety concerns .
  • Upcoming data disclosures: AHA late‑breaking oral will include biomarkers (NT‑proBNP, troponin) and 6MWT at 12 months for 36 ATTR‑CM patients vs baseline .

Estimates Context

  • Wall Street consensus EPS and revenue for Q3 2024 via S&P Global were unavailable at time of query due to provider limits; beat/miss analysis vs consensus cannot be determined at this time. Values would be retrieved from S&P Global if available.

Key Takeaways for Investors

  • Near‑term catalysts: AHA late‑breaking NTLA‑2001 Phase 1 data on Nov 16 (biomarkers/functional capacity), plus active HAELO Phase 3 enrollment—potential stock‑moving events on efficacy/functional readouts .
  • Regulatory momentum lowers risk: FDA IND clearance for MAGNITUDE‑2 (ATTRv‑PN) supports expedited ex‑U.S. pivotal path; study design leverages strong TTR reduction biology .
  • HAE commercial narrative: Functional cure profile for NTLA‑2002 (attack‑free, no chronic therapy) could expand prophylaxis market and drive rapid adoption pending Phase 3 success and 2026 BLA .
  • ATTR‑CM competitive positioning: Deep, rapid, and durable TTR suppression may support superiority vs chronic silencers/stabilizers; robust, event‑driven Phase 3 design aims to capture clinical outcomes across broader severity (incl. NYHA Class III) .
  • Financial runway intact: ~$944.7M cash and reiterated funding into late 2026 provide capacity to prosecute three Phase 3s and first gene insertion program without near‑term dilution pressure, subject to burn trajectory and market conditions .
  • Watch revenue variability: Collaboration revenue is episodic and influenced by partner timing (e.g., AvenCell); focus should remain on clinical/regulatory milestones as primary valuation drivers .
  • Risk flags: Fair value investment marks can add volatility to other income; Phase 3 execution risks (enrollment/event rates), ex‑U.S. PN design considerations, and competitive RNAi/stabilizer dynamics remain key monitoring points .

Sources

  • Q3 2024 press release and financials .
  • Q3 2024 Form 8‑K and Exhibit 99.1 (financials) .
  • Q3 2024 earnings call transcript .
  • Q2 2024 press release/8‑K/call .
  • Q1 2024 8‑K/call .
  • HAE Phase 2 press releases (Sep/Oct) .
  • HAELO Phase 3 initiation (Oct 7, 2024) .
  • AHA late‑breaking presentation announcement (Oct 1, 2024) .